MAUDE Adverse Event Report: ELI LILLY AND COMPANY HUMAPEN LUXURA HALF-DOSE PEN; FOR TREATMENT PURPOSES

Model Number MS9673A

Device Problems Entrapment of Device (1212); Failure to Deliver (2338); Inaccurate Delivery (2339)

Patient Problem Hyperglycemia (1905)

Event Date 07/31/2019

Event Type  Injury  

Manufacturer Narrative

Narrative field: new, updated and corrected information is referenced within the update statements.Please refer to update statement(s) dated 29jan2020.No further follow-up is planned.This report is associated with 1819470-2020-00009 since there is more than one device implicated.Evaluation summary: a consumer reported on behalf of a male patient that the injection screw of the patient's humapen luxura hd device was stuck and the doses were suspected to be inaccurate.The patient experienced increased blood glucose.The device was not returned to the manufacturer for investigation (batch 1201g07, manufactured january 2012).Therefore, it could not be evaluated to confirm the complaint or presence of a malfunction.Malfunction unknown.A complaint history review for the device batch did not identify any atypical findings with regard to injection screw not moving or dose accuracy issues.All humapen luxura hd devices are assessed for injection screw travel at the end of the manufacturing process, thus ensuring device functionality and dose accuracy with high probability.There is no evidence of improper use or storage.

Event Description

Lilly case id: (b)(4).This report is associated with product complaint: (b)(4).This solicited case, reported by a consumer via a patient support program (psp), concerned a (b)(6) year-old male patient of unknown origin.Medical history was not provided.Concomitant medications included insulin glargine for an unknown indication.The patient received insulin lispro (rdna origin) (humalog 100u/ml, cartridge), via a reusable pen (humapen luxura hd) at 2 international unit, thrice daily, subcutaneously, for diabetes mellitus, beginning sometime in (b)(6) 2018.Sometime in (b)(6) 2019, while on insulin lispro treatment, his first humapen luxura hd device had been impaired as the screw had been stuck several times and the insulin stopped being dispensed (pc number: (b)(4) and lot number: unknown) due to which his blood glucose level started to increase at that time (values, units and normal reference range not provided).His healthcare professional (hcp) told him that the humapen luxura hd was impaired so he replaced the first humapen luxura hd approximately sometime in (b)(6) 2019.On (b)(6) 2020, his second humapen luxura hd device screw had been also stuck and the doses were suspected to be inaccurate (as reported) (pc number: (b)(4) and lot number: 1201g07).He also discovered that when the blood glucose level started to increase to reach 500, 522, 600 and so on, it led him to enter the hospital for few hours to return his blood glucose level to normal (units and range not provided).On an unknown date, he was taking his doses using insulin syringe and his hcp told him that the syringe doses were not the same as the humapen luxura hd, so still inaccurate doses.Further details including corrective treatment was not provided.He had not recovered from the events.Insulin lispro treatment was continued.The operator of humapen luxura hd and his/her training status was not provided.The humapen luxura hd general model duration was approximately 21 months (started sometime in mar-2018) and the first suspect humapen luxura hd model duration of use was 15 months (started sometime in (b)(6) 2018) while the second suspect humapen luxura hd duration of use was approximately five months (started sometime in (b)(6) 2019).The first suspect humapen luxura hd device was discontinued sometime in jul-2019 and the second suspect humapen luxura hd, which was manufactured in jan2012, was discontinued on 08-jan-2020; both devices were not returned to the manufacturer.The reporting consumer did not relate the events with insulin lispro treatment therapy while related them with humapen luxura hd devices.Update 23jan2020: upon review of info received 11jan2020 from global product complaint database.Recoded the suspect devices from humapen luxura hd with model number ms9673 to humapen luxura hd with model number ms9673a for pc (b)(4) and (b)(4).Changed the lot number from 120g07 to 1201g07 for product complaint (b)(4) relating to the humapen hd device.Corresponding fields and narrative updated accordingly.Edit 28jan2020: updated medwatch and european and (b)(6) (eu/(b)(6)) fields for expedited device reporting.No new information added.Update 29jan2020: additional information received on 28jan2020 from the global product complaint database.Entered device specific safety summaries (dsss).Updated the medwatch fields/ european and (b)(6) (eu/(b)(6)) device information, and device return status to not returned to manufacturer for pc (b)(4) with unknown associated lot of humapen luxura hd device and pc (b)(4) with lot 1201g07 for humapen luxura hd device.Added date of manufacturer for pc (b)(4).Corresponding fields and narrative updated accordingly.

• Brand Name: HUMAPEN LUXURA HALF-DOSE PEN
• Type of Device: FOR TREATMENT PURPOSES
• Manufacturer (Section D): ELI LILLY AND COMPANY; lilly corporate center; indianapolis IN 46285
• Manufacturer (Section G): PHILLIPS-MEDISIZE CORPORATION; medical device manufacturing; 415 red cedar street; menomonie WI 54751
• Manufacturer Contact: chris davis ; lilly corporate center; indianapolis, IN 46285 ; 3174334585
• MDR Report Key: 9684902
• MDR Text Key: 192408685
• Report Number: 1819470-2020-00010
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K100988
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: MS9673A
• Device Lot Number: 1201G07
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 2 YR